3-methylcyclopentadecan-1-one

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Basic data given: comparable to standard guideline. comparable to guideline study with acceptable restrictions Pre-guideline and pre-GLP study. Only basic data given, but considered sufficiently reliable for the purpose of hazard assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

(no details on test animals, environmental condition of animal room, dermal exposure (duration, occlusive-dressing or not, abraded skin or not), body weight)

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-methylcyclopentadecan-1-one

EC Number:

208-795-8

EC Name:

3-methylcyclopentadecan-1-one

Cas Number:

541-91-3

Molecular formula:

C16H30O

IUPAC Name:

3-methylcyclopentadecan-1-one

Test material form:

not specified

Details on test material:

- Physical state:no data

Test animals

Species:

rabbit

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

No data

Administration / exposure

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg bw

Duration of exposure:

No data

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10 animals/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for toxicity and clinical signs daily for 14 days.
- Necropsy of survivors performed: Yes

Statistics:

No data

Results and discussion

Preliminary study:

Not applicable

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: One animal died on Day 4.

Mortality:

1 animal died on day 4

Clinical signs:

other: Moderate redness was observed in 10/10 animals. Slight oedema in 3/10 and Moderate oedema in 7/10.

Gross pathology:

Liver dark, intestine slightly red and fecal matter dried around anal region in the animal which died.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the available data, the substance is not classified according to the Regulation (EC) No. 1272/2008 and to the GHS as the dermal LD50 is greater than 5000 mg/kg bw in rabbits.

Executive summary:

In an acute dermal toxicity study (limit test), the skin of ten rabbits was exposed to test material at dose of 5000 mg/kg bw. Animals were observed for mortality and clinical signs at least daily for 14 days. 1/10 animal died on Day 4 post exposure. Dermal irritation was observed in all the animals.

Rabbit Dermal LD50 > 5000 mg/kg bw

Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.

This study is considered as acceptable and satisfies the requirement for acute dermal toxicity endpoint.